Aneurysm device and delivery system

ABSTRACT

The present disclosure relates to a self-expanding braided tubular member for treating an aneurysm. The braid can include a distal implant end opposite a proximal implant end. Translating the braid distally from within a tubular delivery member can cause the distal implant end to invert and fold into itself thereby forming an occlusive sack for occluding an aneurysm.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. provisional patent applicationNo. 62/462,685 entitled “ANEURYSM DEVICE AND DELIVERY SYSTEM” and filedFeb. 23, 2017, the contents which are incorporated herein by referenceas if set forth verbatim.

FIELD

This disclosure relates to medical instruments, and more particularly,delivery systems for a device for aneurysm therapy.

BACKGROUND

Aneurysms can be complicated and difficult to treat. For example,treatment access may be limited or unavailable when an aneurysm islocated proximate critical tissues. Such factors are of particularconcern with cranial aneurysms due to the presence of brain tissuesurrounding cranial vessels.

Prior solutions have included endovascular treatment access whereby aninternal volume of the aneurysm sac is removed or excluded from arterialblood pressure and flow.

Alternative to endovascular or other surgical approaches can includeocclusion devices. Such devices have typically incorporated multipleembolic coils that are delivered to the vasculature using microcatheterdelivery systems. For example, when treating cranial aneurysms, adelivery catheter with embolic coils is typically first inserted intonon-cranial vasculature through a femoral artery in the hip or groinarea. Thereafter, the catheter is guided to a location of interestwithin the cranium. The sac of the aneurysm can then be filled with theembolic material to create a thrombotic mass that protects the arterialwalls from blood flow and related pressure. One particular type ofocclusive approach endeavors to deliver and treat the entrance or “neck”of the aneurysm as opposed to the volume of the aneurysm. In such “neck”approaches, by minimizing blood flow across the neck, then a venostasisin the aneurysm may be achieved. In turn, a thrombotic mass maynaturally form without having to deliver embolic materials, aspreviously described. This is preferable to masses formed from embolicmaterial since a natural mass can improve healing by reducing possibledistention from arterial walls and permits reintegration into theoriginal parent vessel shape along the neck plane of the aneurysm. It isunderstood that the neck plane is an imaginary surface where the innermost layer of the parent wall would be but for the aneurysm. However,neck-occlusive approaches are not without drawbacks. It is typical forneck-occlusive approaches to fail to impede flow into blood vesselswhile also blocking the aneurysm neck in the parent vessel. This canunintentionally lead to severe damage if the openings of the vessels areblocked. Furthermore, embolic coils do not always effectively treataneurysms as re-canalization of the aneurysm and/or coil compaction canoccur over time.

Several embodiments of an occlusion device are described in U.S. Pat.No. 8,998,947. However, this approach relies upon the use of emboliccoils or mimics the coil approach to obtain a safe packing density andtherefore unnecessarily risks rupture of the aneurysm. Furthermore, thisapproach fails to teach a delivery system whereby an occlusion devicecan be re-positioned after initial positioning of its aneurysm occlusionstructure to ensure patient safety associated with precise positioning.

It is therefore desirable to have a device which easily, accurately, andsafely occludes a neck of an aneurysm or other arterio-venousmalformation in a parent vessel without blocking flow into perforatorvessels communicating with the parent vessel.

SUMMARY

In some aspects, the present disclosure relates to a medical device fortreating an aneurysm. The device can include a self-expanding braidedtubular implant (hereinafter “braid”) with a lumen that has a distalimplant end and a proximal implant end. The distal implant end can beopposite the proximal implant end. Distal translation of the braid fromwithin a tubular delivery member can cause the distal implant end toinvert and fold into itself thereby forming an occlusive sack foroccluding an aneurysm.

In certain embodiments, the tubular delivery member can be disposedabout the implant and have a distal end that is releasably connected tothe distal implant end of the braid. The braid can have a longitudinalaxis between the distal implant end and the proximal implant end. Thebraid can be invertible about the longitudinal axis by distallytranslating the braid about the axis.

In certain embodiments, the lumen of the braid can include apre-fabricated break that is disposed between the distal and implantends. The break can be formed from localized heat treatment zone that iskink-preventative and configured to induce gradual folding and/orinversion of the braid. The break can be disposed between the distal andimplant ends. The break can be configured for the occlusive sack to formwhen the distal implant end is translated toward or contacts a dome ofthe aneurysm. In some embodiments, one or more regions or areas of thedistal end of the distal implant end are substantially atraumatic orrounded and configured to minimize kinking of the braid duringinversion. In certain embodiments, continuing to translate the braidupon formation of the occlusive sack can lead to formation of a secondsack within the occlusive sack. Additional sacks can be formed withinthe first and second sacks as needed or required (e.g. to achieve adesired packing density or to further support the first and secondsacks). It is understood that each sack can be formed from a respectiveportion of the braid inverting and folding into itself.

In certain embodiments, the proximal implant end is operable tomechanically attach to a delivery system. The delivery system caninclude a catheter and a pushing mechanism disposed in the catheterand/or including a hypotube, the pushing mechanism operable to translatethe braid toward the aneurysm. In certain embodiments, the occlusivesack can be substantially spherical, ellipsoidal, or otherwiseconformable to an asymmetric aneurysm, for example, an aneurysm withmultiple sacs, irregular dome or walls. The proximal implant end canalso be less pliable and/or can have less material strength than thedistal implant end. An outer surface of the braid can also include aplurality of interstices (e.g. a mesh surface).

The invertibility, pliability, and/or porosity of the braid can beselectively designed for treatment of an aneurysm having a particularshape, by varying properties of the interstices among different portionsof the braid.

In other embodiments, a method of delivering an occlusion device to ananeurysm in a blood vessel in a patient is disclosed. The method caninclude positioning an occlusion device within a delivery tube (e.g. atube that can be pushed or caused to translate the occlusion device),the occlusion device comprising any self-expanding braid of thisdisclosure; distally sliding the braid towards the aneurysm from withinthe delivery tube; expanding a distal implant end of the braid from acollapsed condition to a deployed condition; and inverting the distalimplant end of the braid to form a sack for occluding the aneurysm.

In certain embodiments, the distal implant end of the braid beginsexpanding immediately as the braid exits a distal end of the deliverytube. In certain embodiments, when the sack is formed, it can include apredetermined packing density or density range. In certain embodiments,the method can include positioning a microcatheter within thevasculature and then positioning the occlusion device assembled with thedelivery tube inside the microcatheter; and delivering the occlusiondevice and the delivery tube assembled with the microcatheter to theaneurysm. In certain embodiments, the method can also include: imagingthe sack with respect to the aneurysm; determining whether the aneurysmis occluded by the sack; and distally or proximally sliding the braid toadjust the sack and to occlude the aneurysm.

In certain embodiments, imaging the sack with respect to the aneurysmincludes determining whether a necessary packing setting for the sack toocclude the aneurysm and moving the braid (e.g. by distally orproximally sliding the braid) to adjust the sack.

In other embodiments, a method of delivering an occlusion device to ananeurysm in a blood vessel in a patient is disclosed. The method caninclude: positioning the occlusion device within a delivery tube, theocclusion device comprising a self-expanding braid; distally sliding abraid toward the aneurysm; expanding (e.g. radially expanding) a distalimplant end of the braid from a collapsed condition to a deployedcondition as the braid approaches a dome of the aneurysm; and invertingthe distal implant end of the braid to form an occlusive sack that packsthe aneurysm to a predetermined packing density and occludes theaneurysm.

In certain embodiments, the braid includes a first break that is definedby a size of the sack for occluding the aneurysm. The braid can alsoinclude a second break proximal of the first break. In this respect, themethod can also include distally sliding the braid toward the aneurysmafter formation of the first sack; and inverting the braid at the secondbreak to form a second sack internal to the first sack.

In certain embodiments, the method can also include: distally slidingthe braid toward the aneurysm after formation of the first sack; andinverting the braid to form a second sack internal to the first sack.

In certain embodiments, the method can also include: continuing todistally slide the braid toward the aneurysm after formation of thefirst sack thereby packing the sack with one or more unexpanded portionsof the braid.

In certain embodiments, the method can also include: determining aposition of the sack relative to the aneurysm and if the position failsto fit or conform to the sack, then the braid may be proximallytranslated thereby causing the sack to collapse back into the braid; andwithdrawing the braid from the aneurysm.

In other embodiments, this disclosure relates to a delivery system foran occlusive device for treating an aneurysm. In some embodiments, thedelivery system can include a delivery tube that includes a distal endand a proximal end. The delivery tube can be slidably disposed within amicrocatheter. A pushing mechanism can be slidably disposed within thedelivery tube. The occlusive device can be slidably disposed within thedelivery tube and mechanically attached to the pushing mechanism. Theocclusive device can include a braid having a lumen with a distalimplant end opposite a proximal implant end. The pushing mechanism canbe operable to distally translate the occlusive device to a deployedcondition within the aneurysm, wherein distally translating the braid tothe deployed condition causes the distal implant end to invert and foldinto itself thereby forming an occlusive sack for the aneurysm.

In certain embodiments, the proximal implant end of the braid may becapable of mechanical attachment, detachable or otherwise, to the distalend of the pushing mechanism.

In other embodiments, at least a portion of the braid defines aplurality of interstices with openings for occlusion of the aneurysm. Inother embodiments, the proximal implant end of the braid can be attachedto and foldable over an inner portion of the pushing mechanism.

In other embodiments, the braid can be attached to and foldable over aninner portion of the pushing mechanism. The braid may also be fillableas the braid is folded. In certain embodiments, the braid can beinvertible as the braid distally slides and exits the delivery tube. Thesack may be a collapsible cage-like vaso-occlusive structure.

In other embodiments, the distal end of the delivery member can includeopposed gripping arms (e.g., upper and lower). One or both gripping armscan be pivotable toward the other gripping arm to release the braid fromthe delivery tube when the braid forms a sack about the. In otherembodiments, the pushing mechanism can also include an inner passagethrough which at least one embolic coil is insertable into the braidwhen the braid forms a sack within the aneurysm.

In other embodiments, the pushing mechanism can include radiopaquematerial (e.g. the distal end, the proximal end, etc.).

In other embodiments, a method is disclosed for delivering an occlusiondevice to an aneurysm in a blood vessel in a patient. The methodincludes: positioning a delivery system of the occlusion device within amicrocatheter in the vasculature, the delivery system including adelivery tube having a distal end and a proximal end. The deliverysystem may also include a pushing mechanism that is slidably disposedwithin the delivery tube, the pushing mechanism comprising a distal endand a proximal end. The method may include slidably positioning aself-expanding braid of the occlusion device within the delivery tube,the braid comprising a distal end and a proximal end; detachablyattaching the proximal end of the braid to the distal end of the pushingmechanism; selectively inserting the microcatheter with the deliverysystem and the occlusion device into vasculature of the patient to reachthe aneurysm; distally sliding the braid, by the pushing mechanism, inthe delivery tube toward the aneurysm thereby causing the braid toradially expand and move from a collapsed condition within the deliverytube to a deployed condition within the aneurysm as the distal end ofthe braid is moved outside and away from the distal end of the deliverytube; and releasing the occlusion device and withdrawing themicrocatheter and the delivery system from the patient.

In other embodiments, the method can also include: forming, by thebraid, a sack within the aneurysm by distally sliding the braid to thedeployed condition; distally sliding the pushing mechanism to the distalend of delivery tube until the braid folds; and folding the braidthereby filling the sack and securing the occlusion device within theaneurysm to occlude flow into the aneurysm.

In other embodiments, the method can also include: forming the sackwithin the aneurysm by inverting the braid as the braid distally slidesand exits the delivery tube and/or bulges against a wall of theaneurysm.

In other embodiments, the method can also include: deflecting thepushing mechanism as the braid is inverted and reaches a dome of theaneurysm; filling the sack as the braid is inverted; and/or continuingto distally translate, by the pushing mechanism, the braid into theaneurysm until the proximal end of the braid reaches the distal end tipof the pushing mechanism.

In other embodiments, the method can also include: attaching theproximal end of the braid to an inner portion of the pushing mechanism;and/or filling the sack by folding the braid until the braid is at leastlevel with a neck of the aneurysm.

In other embodiments, the method can also include: forming, by thebraid, a sack within the aneurysm by distally sliding the braid to thedeployed condition; forming a gripping mechanism for detaching the sackfrom the delivery system, the gripping mechanism being formed by a pairof opposed gripping arms formed at a distal end of the delivery tube,one or both gripping arms being pivotable toward the other gripping arm;and/or detaching, by the grabbing mechanism of the delivery system, thesack from the delivery system by pivoting one or both arms away from theother.

In other embodiments, the method can also include: inserting at leastone embolic coil through an inner passage of the pushing mechanism andinto the sack to adjust the packing density.

In other embodiments, the method can include forming, by inverting thebraid, a first occlusive sack within the aneurysm by distally slidingthe braid from the delivery tube toward the aneurysm; distally slidingthe braid toward the aneurysm after formation of the first sack; andinverting the braid to form a second sack within the first sack. Formingthe first and/or second sack can cause flow into the aneurysm to bedeflected, diverted, and/or slowed.

In other embodiments, the method can include forming, by inverting thebraid, a first occlusive sack within the aneurysm by distally slidingthe braid from the delivery tube toward the aneurysm; distally slidingthe braid toward the aneurysm after formation of the first sack;inverting the braid to form a second sack within the first sack;distally sliding the braid toward the aneurysm after formation of thesecond sack; and inverting the braid to form a third sack within thefirst and second sacks. Forming the first, second and/or third sack cancause flow into the aneurysm to be deflected, diverted, and/or slowed.It is contemplated that only one sack could be used or more than threesacks could be formed and used for purposes of deflecting, diverting,and/or slowing flow into the aneurysm.

Other aspects and features of the present disclosure will becomeapparent to those of ordinary skill in the art, upon reviewing thefollowing detailed description in conjunction with the accompanyingfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will now be made to the accompanying drawings, which are notnecessarily drawn to scale.

FIG. 1 depicts an example occlusion device of this disclosure deployedinto an aneurysm.

FIG. 2 is a schematic side view of an exemplary delivery system with anocclusion device held in a collapsed condition within a microcatheter.

FIG. 3 is an enlarged schematic side view of the delivery system of FIG.2 along section A-A;

FIG. 4 is a flow diagram for a method of delivering an occlusion deviceto the vasculature using the herein disclosed delivery system;

FIG. 5A is an enlarged schematic side view of the delivery system ofFIG. 2 along section B-B of FIG. 4;

FIG. 5B is an enlarged schematic side view of the delivery system ofFIG. 2 along section C-C of FIG. 4;

FIG. 5C is an enlarged schematic side view of the delivery system ofFIG. 2 along section D-D of FIG. 4;

FIG. 5D is an enlarged schematic side view of the delivery system ofFIG. 2 along section E-E of FIG. 4;

FIG. 6A is an enlarged perspective schematic view of section F-F acrossits center line showing an exemplary proximal implant end of the braidin communication with an exemplary pushing mechanism;

FIG. 6B is an enlarged schematic overview showing an exemplaryattachment system as between a delivery tube, pushing mechanism andcatheter in an embodiment of the delivery system;

FIG. 6C is an enlarged schematic view showing an exemplary attachmentsystem as between a delivery tube, pushing mechanism and catheter in anembodiment of the delivery system.

FIG. 6D is an enlarged schematic view showing an exemplary attachmentsystem as between a delivery tube, pushing mechanism and catheter in anembodiment of the delivery system.

FIG. 6E is an enlarged schematic view showing an exemplary attachmentsystem as between a delivery tube, pushing mechanism with the catheterremoved in an embodiment of the delivery system.

FIG. 6F is an enlarged schematic view showing an exemplary attachmentsystem as between a delivery tube, pushing mechanism with the catheterremoved in an embodiment of the delivery system.

FIG. 7 is an enlarged schematic side view of the attachment system ofFIG. 6E along section G-G.

FIG. 8 is a schematic side view of an exemplary delivery system with anocclusion device being deployed with an embolic coil.

FIG. 9 is a flow diagram for a method of delivering an occlusion device.

FIG. 10 is a flow diagram for a method of delivering an occlusion deviceusing the herein disclosed delivery system.

FIG. 11A depicts an example braid of this disclosure.

FIG. 11B depicts an example braid of this disclosure deployed.

FIG. 11C depicts an example braid with embolic coil of this disclosure.

FIG. 12A is an enlarged view one step of an exemplary delivery systemdevice being deployed into an aneurysm in accordance with thisdisclosure, wherein the system is shown moving from a collapsedcondition to a deployed condition.

FIG. 12B is an enlarged view one step of an exemplary delivery systemdevice being deployed into an aneurysm in accordance with thisdisclosure, wherein the system is shown moving from a collapsedcondition to a deployed condition.

FIG. 12C is an enlarged view one step of an exemplary delivery systemdevice being deployed into an aneurysm in accordance with thisdisclosure, wherein the system is shown moving from a collapsedcondition to a deployed condition.

FIG. 12D is an enlarged view one step of an exemplary delivery systemdevice being deployed into an aneurysm in accordance with thisdisclosure, wherein the system is shown moving from a collapsedcondition to a deployed condition.

FIG. 12E is an enlarged view one step of an exemplary delivery systemdevice being deployed into an aneurysm in accordance with thisdisclosure, wherein the system is shown moving from a collapsedcondition to a deployed condition.

FIG. 12F is an enlarged view one step of an exemplary delivery systemdevice being deployed into an aneurysm in accordance with thisdisclosure, wherein the system is shown moving from a collapsedcondition to a deployed condition.

FIG. 12G is an enlarged view one step of an exemplary delivery systemdevice being deployed into an aneurysm in accordance with thisdisclosure, wherein the system is shown moving from a collapsedcondition to a deployed condition.

FIG. 12H is an enlarged view one step of an exemplary delivery systemdevice being deployed into an aneurysm in accordance with thisdisclosure, wherein the system is shown moving from a collapsedcondition to a deployed condition.

FIG. 12I is an enlarged view one step of an exemplary delivery systemdevice being deployed into an aneurysm in accordance with thisdisclosure, wherein the system is shown moving from a collapsedcondition to a deployed condition.

DETAILED DESCRIPTION

Although example embodiments of the disclosed technology are explainedin detail herein, it is to be understood that other embodiments arecontemplated. Accordingly, it is not intended that the disclosedtechnology be limited in its scope to the details of construction andarrangement of components set forth in the following description orillustrated in the drawings. The disclosed technology is capable ofother embodiments and of being practiced or carried out in various ways.

It must also be noted that, as used in the specification and theappended claims, the singular forms “a,” “an” and “the” include pluralreferents unless the context clearly dictates otherwise. By “comprising”or “containing” or “including” it is meant that at least the namedcompound, element, particle, or method step is present in thecomposition or article or method, but does not exclude the presence ofother compounds, materials, particles, method steps, even if the othersuch compounds, material, particles, method steps have the same functionas what is named.

In describing example embodiments, terminology will be resorted to forthe sake of clarity. It is intended that each term contemplates itsbroadest meaning as understood by those skilled in the art and includesall technical equivalents that operate in a similar manner to accomplisha similar purpose. It is also to be understood that the mention of oneor more steps of a method does not preclude the presence of additionalmethod steps or intervening method steps between those steps expresslyidentified. Steps of a method may be performed in a different order thanthose described herein without departing from the scope of the disclosedtechnology. Similarly, it is also to be understood that the mention ofone or more components in a device or system does not preclude thepresence of additional components or intervening components betweenthose components expressly identified.

As discussed herein, vasculature of a “subject” or “patient” may bevasculature of a human or any animal. It should be appreciated that ananimal may be a variety of any applicable type, including, but notlimited thereto, mammal, veterinarian animal, livestock animal or pettype animal, etc. As an example, the animal may be a laboratory animalspecifically selected to have certain characteristics similar to a human(e.g., rat, dog, pig, monkey, or the like). It should be appreciatedthat the subject may be any applicable human patient, for example.

As discussed herein, “operator” may include a doctor, surgeon, or anyother individual or delivery instrumentation associated with delivery ofa braid body to the vasculature of a subject.

Cerebrovascular aneurysms are known to be treated using embolic coils,which are delivered to the aneurysm sack via a microcatheter anddetached in situ. It is understood that “packing density” is the volumeof the aneurysm sack occupied by the coil mass. In previous coilapproaches, multiple coils (e.g. five coils) have been used to pack theaneurysms and the packing density can typically range between 15-25%,depending on the aneurysm size. The herein disclosed device improves onuse of embolic coils by using a single device without a need for even asingle coil to pack the device. Instead, the disclosed device isoperable to seal the aneurysm neck and pack the aneurysm to a higherpacking density than using coils. In practice, the packing density canbe as increased 25-50% depending on the length of braid in the aneurysm,or double what can be achieved with conventional coils. However, themultiple braid layers formed as the braid packs the aneurysm may meanthat a lower packing density may achieve blood flow alteration andcoagulation in a way that a lower packing density may achieve the samelevel of occlusion. This allows for the aneurysm neck to heal.

In contrast, in previous embolic-based approaches, packing the aneurysmrequired in placement of coils into the aneurysm sack until the aneurysmobtained the desired packing density to occlude the aneurysm. However,obtaining such a packing density was difficult, time consuming, andaneurysm morphology (e.g. wide neck, bifurcation, etc.), and the likerequired ancillary devices such a stents or balloons to support the coilmass and obtain the desired packing density. Furthermore, aneurysmstreated with multiple coils often reanalyze or compact as a result ofpoor coiling, lack of coverage across the aneurysm neck, as a result offlow, or even aneurysm size.

The occlusion device 1 and corresponding delivery system 30 disclosedherein addresses the drawbacks of previous approaches, including lowpacking density, compaction and recanalization of aneurysms.

Turning to FIG. 1, an example occlusion device 1 of this disclosure isshown deployed into an aneurysm A of blood vessel BV but not yetreleased from its delivery system. The catheter 20 has been delivered tothe aneurysm A and as shown and discussed more particularly below,occlusive sack 12 of braided tubular implant 10 (hereinafter alsoreferred to “braid” or “braid 10”) of device 1 has formed apredetermined shape and structure that outlines and supports the wallsof the aneurysm A so as to occlude aneurysm A.

FIG. 2 depicts a schematic side view of braid 10 and delivery system 30prior to being positioned in a location of interest in the vasculaturefor occluding aneurysm A. The braid 10 can include a lumen with a distalimplant end 16 opposite a proximal implant end 14, as shown moreparticularly in FIG. 3. Specifically, FIG. 3 is an enlarged schematicside view of the delivery system of FIG. 2 along section A-A prior todeployment. System 30 can include a pusher delivery tube 34 with aninner lumen and a braid pushing mechanism 38. System 30 can deliver anocclusive device, which includes braid 10, to a location of interest(e.g. a lesion site) using a microcatheter 20. System 30 may bepreplaced in microcatheter 20. In certain embodiments, microcatheter 20can be pre-placed, with or without system 30, at a level of the aneurysmneck and used to track the device 1 to the lesion. Mechanism 38 may betubular, solid, elongate, and/or be pliable to be able to pass throughtortuous pathways of the vasculature within delivery tube 34 and/ormicrocatheter 20. Mechanism 38 can include an inner lumen and bedisposable or capable of functioning with a hypotube. For example, ahypotube can be attached or in communication with mechanism 38 todistally slide mechanism 38 toward the aneurysm A.

In this respect, mechanism 38 may be slidably disposed within deliverytube 34, wherein mechanism 38 can be in mechanical connection with braid10 at attachment 36. When braid 10 is mechanically attached to pushingmechanism 38 at attachment 36, distally translating, sliding, orotherwise moving mechanism 38 toward the aneurysm can cause a distalimplant end 16 of braid 10 to begin moving from a collapsed condition toa deployed condition, as discussed below. Both delivery tube 34 andmechanism 38 can extend from the proximal 24 to the distal end 26 ofmicrocatheter 20.

It is understood that braid 10 can include a self-expanding braid fortreating an aneurysm. The inner lumen of braid 10 can form aself-expanding multi-filament outer surface that can include a mesh. Itcan be seen that mechanism 38 is disposed proximal of braid 10 and braid10 is in communication with mechanism 38 across attachment 36 atproximal implant end 14. Braid 10 may be attached to attachment 36 bybeing crimped thereon or by a detachable connection. In certainembodiments, proximal implant end 14 may be inserted within the distalend of mechanism 38 at attachment 36 wherein mechanism 38 can then beattached therewith or thereon. However, attachment 36 is not so limitedand instead braid 10 may be slidably, detachably inserted over orotherwise with attachment 36.

Prior to deployment within an aneurysm A, distal implant end 16 of braid10 is adjacent or in contact with distal end 46 of delivery tube 34.Delivery tube 34 may also include one or more fasteners 32 operable tosecurely fasten braid 10 in place prior to deployment. The area of braid10 of distal implant end 16 adjacent or in communication with fastener32 may be substantially atraumatic and/or rounded so to minimize kinkingor other damage to the adjacent area of braid 10. Fastener 32 mayinclude a crimping, soldering, bracing, adhesive, pressure cuff,welding, or other fastener means, including clamps, or the like, so thatdelivery tube 34 is secured therewith but translation of mechanism 38and braid 10 is still permitted when actuation is desired.

Braid 10 may be operable to expand over the neck of the aneurysm Aduring delivery which can substantially reduce and/or prevent furtherblood flow from the parent vessel into the aneurysm sac. Portions ofbraid 10 on or proximate end 16 may be more pliable than portions ofbraid 10 on or proximate end 14 in order to induce self-expansion duringdelivery and inversion as braid 10 forms its predetermined, sack-likeshape within aneurysm A (see, e.g., FIG. 1). The braid 10, including itsouter surface, can be self-expanding and made from nitinol withinterwoven platinum filaments for radiopacity. Braid 10 is not solimited, however, and any material or combination of materials can beused to form an outer surface of braid 10 can be used as needed orrequired.

Turning to FIG. 4, a flow diagram for a method 400 is shown for safelyand precisely delivering an example braid 10 to the vasculature. As canbe seen, in step 405 of method 400, the occlusion device 1 is assembledwith a microcatheter 20. The assembly between microcatheter 20 anddevice 1 can take place before being introduced into the vasculature. Instep 410, device 1, including system 30, may now have been selectivelypositioned at the lesion site and mechanism 38 can begin its distaltranslation of the braid 10. As can be seen in step 410, braid 10 beginsexpanding and/or inverting as its distal implant end 16 moves away fromdistal end 26 of catheter 20 and/or delivery end 46 (not identified inthis figure) of delivery tube 34 to form sack 12 within aneurysm A beingtreated (see, e.g., formed sack 12 of device 1 that occludes aneurysm Aof FIG. 1).

In certain embodiments, sack 12 begins being formed as braid 10 isadvanced to the vicinity of the neck or dome of the aneurysm such thatmechanism 38, attachment 36, and/or portions of delivery tube 34 are atthe level of the neck as seen under fluoroscopy. However, device 1 isnot so limited and instead braid 10 can begin inverting and folding intoitself to form sack 12 as distal implant end 16 simply distally slidesaway from delivery tube 34 and/or catheter 20. As shown in step 415,sack 12 is now taking a generally spherical shape as braid 10 istranslated distally deeper into aneurysm A and/or further away fromcatheter 20 and tube 34. In moving between steps 405 to 415, the outerdiameter of the braid 10 radially expands to a diameter greater than themicrocatheter 20 as sack 12 is formed. The braid wire count ofinterstices of braid 10 that may form the outer surface can varydepending of the diameter of the sack 12 or sacks needed to occlude theaneurysm. For example, in order to induce formation of the predeterminedshape and strength of sack 12, distal implant end 16 of braid 10 may bemore pliable than proximal implant end 14 and portions of braid 10 mayvary from most pliable on or about end 16 and less pliable on or aboutend 14. Interstices of braid 10 may also form openings for occlusion ofthe aneurysm.

Such distal movement of mechanism 38 and initial formation of sack 12 ofbraid 10 is more clearly shown in FIG. 5A which is an enlarged view ofsection B-B of FIG. 4. As distal implant end 16 of braid 10 distallytranslates toward aneurysm A and away from end 26 of microcatheter 20,the distal implant end 16 of braid 10 can begin to invert and fold intoitself thereby beginning to form an occlusive sack 12 for occluding ananeurysm. This is more clearly shown in FIG. 5B, which is an enlargedview of section C-C of FIG. 4. Mechanism 38 may be driven by a hypotubefrom its proximal end by an operator or the like. It is understood thatbraid 10 can also be attached to and/or foldable over an inner portionof mechanism 38, for example at attachment 36.

In step 420, mechanism 38 may continue to be distally translated whiledistal implant end 16 of braid 10 continues inverting as it approachesor contacts the dome of aneurysm A. Braid 10 can also begin invertingimmediately as it exits catheter 20 (see, e.g., step 410 of FIG. 5A). Itcan be seen that sack 12 has now completely expanded into itspredetermined, spherical shape designed to conform to the shape ofaneurysm A. This is more clearly shown in FIG. 5C which is an enlargedview of section D-D, wherein sack 12 can be seen in the spherical shape.More specifically, in moving between steps 405 and 420 as shown betweenFIGS. 5A-5C, mechanism 38 distally translates braid 10 until braid foldsabout its distal implant end 16 to form the sack 12. Sack 12 may take onany shape necessary to occlude the respective aneurysm A.

Between steps 420 to 425, mechanism 38 continues to distally slide untilunexpanded, braid portion(s) 17 proximal of sack 12 folds and randomlyfills sack 12, as shown more particularly in FIG. 5D, which is anenlarged view of section E-E. Sack 12 can be the depicted sphericalshape and formed to impart a predetermined packing density and portion17 which is formed with braid 10 has filled sack 12 to further reinforcesack 12. In other words, as the braid 10 reaches the dome of theaneurysm, the braid portion(s) 17 proximal to sack 12 coming frommechanism 38 can be forced to deflect and start filling the sack 12 asshown starting in step 415.

In step 430, with the sack 12 fully formed in a manner sufficient toocclude aneurysm A, braid 10 can be detached from attachment 36.However, if sack 12 is not precisely positioned or if needs to be resetwithin aneurysm A for safe occlusion without risk of rupture, braid 10,including sack 12, can be retracted back into delivery tube 34 byproximally moving mechanism 38. It is understood that when sack 12 isfully formed, it is capable of packing aneurysm A with a 15-25% packingdensity without the need for any embolic coils. However, braid 10 can bedesigned to achieve a packing density of 40%, 50%, or less than 15-25%,as needed or required. The change in packing density can be affected bychanging the length or diameter of the braid 10. A longer or shorterbraid 10 in the same aneurysm A can change the amount of braid deployed,which in turn can dictate the number of sacks 12 formed and the amountof unexpanded, braid portion 17 filling the sack 12. The same can holdtrue for the diameter of the braid 10, a larger diameter filling more ofthe aneurysm A in less length, but at a lower density. The operator canthen choose between the differing parameters of a braid 10 for eachparticular aneurysm A.

In step 435, because sack 12 has been properly positioned and formedwithin aneurysm A, braid 10 has been detached from mechanism 38 andmechanism 38 can now be retracted therefrom. As shown, opposing grasperarms 42 a, 42 b can be formed with the microcatheter 20 or delivery tube34 and withdrawn proximally so arms 42 a, 42 b can release sack 12formed by expanding braid 10. It is understood that some or all of arms42 a, 42 b can be radiopaque so that positioning and detachment can bemonitored and/or driven under fluoroscopy.

One example of attachment 36 is shown in FIG. 6A which is an enlargedperspective schematic view of section E-E of step 425 across center linein order to show braid 10 in communication with mechanism 38. It can beseen that mechanism 38 may include a pull wire 39 that hooks into orattaches to braid 10 and similarly can be released therefrom and thatattachment will be secure so long as pull wire 39 is not pulledproximally. If pull wire 39 is pulled back braid 10 can be released.FIG. 6A is merely one way that mechanism 38 may attach to braid 10across attachment 36 and any number of attachment means are contemplatedas needed or required.

Another example of how system 30 may release braid 10 is shown in FIG.6B. In a first step 605B of method 600B, mechanism 38′ is shown in acollapsed condition within delivery tube 34′ and catheter 20. Mechanism38′ includes a substantially elongate portion 37′ that generally runsalong the inner cavity or lumen of tube 34′ leaving a space between theelongate portion 37′ and the tube 34′. Portion 37′ may be axiallyaligned with tube 34′. A base portion 33′ of mechanism 38′ may also beincluded disposed on a proximal end of mechanism 38′. Portion 33′ may atleast be wider than portion 37′ and can extend to the inner surface oftube 34′. During use, braid 10 can be axially positioned over the spacebetween portion 37′ and tube 34′, advanced over portion 37′, and securedto portion 33′. In step 610B, it can be seen that mechanism 38′ has beendistally translated so that portion 37′ is now distal of tube 34′ andcatheter 20. Base 33′ has similarly been distally translated until itcontacts protrusions 41′ of tube 34′. When base 33′ contacts protrusion41′ in step 610B, protrusion 41′ will be distal of tube 34′ so thatproximal implant end 14 of braid 10 is free to detach. Protrusion 41′may also include a gap or space 43′ into which end 14 of braid 10 can beattached. When space 43′ is distal of catheter 20 and tube 34′, in thoseembodiments where end 14 was previously fastened at space 43′, end 14may now freely disengage and release.

Protrusions 41′ may be members or extensions of tube 34′ that inwardlyprotrude to reduce the inner diameter thereabout to be less than adiameter of base 33′. In this regard, only one protrusion 41′ may beprovided integrally formed with tube 34′ or detachably connected andpositioned therewith. However, method 600B is not so limited and morethan one protrusion 41′ can be provided as well as a cylindricalprotrusion 41′, or any other protrusion shaped and designed to reducethe inner diameter to prevent base 33′ from moving passed.

Another example of how system 30 may release braid 10 is shown in FIG.6C-FIG. 6F. In FIG. 6C, a schematic is shown of an exemplary prototype.FIG. 6D is a photograph of an exemplary prototype exemplifying theembodiment shown in FIG. 6C. Braid 10 is depicted in both FIGS. 6C and6D in a deployed condition wherein sack 12 is formed distal of catheter20 and tube 34″. Mechanism 38″ in this embodiment is mechanicallyattached to braid 10 via attachment 36″, as more clearly shown in FIGS.6E and 6F. Specifically, in FIG. 6E, catheter 20 has been removed toshow braid 10 interconnected with mechanism 38″ at attachment 36″. InFIG. 6F, mechanism 38″ has been detached from braid 10. In practice,mechanism 38″ and catheter 20 can now be removed from the vasculatureand from the patient altogether leaving occlusive sack 12 selectivelypositioned and formed to occlude aneurysm A.

Attachment 36″ is more clearly shown in FIG. 7 which is an enlargedperspective schematic view of section G-G of FIG. 6E showing end 14 ofbraid 10 in communication with mechanism 38″. It can be seen thatmechanism 38″ may include a releasable attachment interface formed by aninterlinking member 39″ about its distal end 46. Member 39″ may beintegrally formed with mechanism 38″ and be constructed from a recess orchannel portion operable to securely engage with attachment portion 11of braid 10. Portion 11 may in turn be a separate portion fastened to,formed with, or otherwise disposed on end 14 of braid 10. Portion 11 mayinclude a corresponding channel or recess operable to detachably,securely engage with member 39″. In practice, member 39″ may be securelyengaged with portion 11 within delivery tube 34 prior to delivery to thevasculature. However, the mechanism 38″ and braid 10 are not so limitedand engagement can occur contemporaneous with delivery of system 30being delivered to the vasculature. When the operator desires to deliverand release sack 12 with aneurysm A, braid 10 may be advanced distallyfrom catheter 20 and/or delivery tube 34 by moving mechanism 38″. Oncemember 39″ is distal of tube 34, corresponding portion 11 of braid 10can be released therefrom. Mechanism 38″ can then be retracted andsystem 30 can be removed from the location of interest in thevasculature. It is understood that FIG. 7 is merely one way that apushing mechanism of the herein disclosed system 30 may attach anddetach to end 14 of braid 10 across attachment 36″ and any number ofattachment means are contemplated as needed or required.

FIG. 8 is a schematic side view of another example delivery system 30with device 1 in the process of being deployed and sack 12 in theprocess of being formed. In this embodiment, a coil 33 is also assembledwith the delivery system 30 for later filling sack 12 to furtherfacilitate packing of aneurysm A. It is understood that one or moreadditional coils can be inserted with proximal implant end 14 as neededor required. System 30 is not so limited, however, and braid 10 caninclude portions behind sack 12 that do not invert to form a sack.Instead, these aft portions are capable of being slid distally intoformed sack 12 similar to adjusting a packing density delivered by sack12 (see, e.g., FIGS. 12A-12I).

FIG. 9 is a flow diagram for a method 900 of delivering an occlusiondevice. In step 905, a self-expanding braid inverts as it distallytranslates from a delivery catheter into the aneurysm. In step 910, thebraid forms an occlusive sack that conforms to the size and/or shape ofthe aneurysm. The braid may invert and/or radially expand in step 910 toform the occlusive sack. In step 915, the braid continues distallytranslating and when the braid reaches the top of the aneurysm, portionsof the braid cease inverting (e.g., portions of the braid proximal theocclusive sack) and are in a non-inverted condition. In someembodiments, portions of the braid proximal the occlusive sack are in anon-inverted condition (e.g., unexpanded) as the braid is distallytranslated deeper into the aneurysm. In step 920, the portions of thebraid in the non-inverted condition distally translate and fill theocclusive sack inside the aneurysm to a predetermined packing density.The density can be increased at least 25%, between 25-50%, or as much as75% more than existing coil approaches.

FIG. 10 is a flow diagram for a method 1000 of delivering an occlusiondevice using the herein disclosed delivery system. Step 1005 includesselectively positioning a microcatheter in the vasculature. Step 1010includes slidably positioning a delivery system of the occlusion devicewithin the microcatheter, the delivery system comprising a delivery tubecomprising a distal end and a proximal end and a pushing mechanismslidably disposed within the delivery tube, the pushing mechanismcomprising a distal end and a proximal end. Step 1015 includes slidablypositioning a self-expanding braid of the occlusion device within thedelivery tube, the braid comprising a distal end and a proximal end.Step 1020 includes detachably attaching the proximal end of the braid tothe distal end of the pushing mechanism. Step 1025 includes advancingthe delivery system to the vasculature to the aneurysm. Step 1030includes distally sliding the braid, by the pushing mechanism, in thedelivery tube toward the aneurysm thereby causing the braid to invertand/or radially expand whiling moving from a collapsed condition withinthe delivery tube to a deployed condition within the aneurysm as thedistal end of the braid is moved outside and away from the distal end ofthe delivery tube. Step 1035 includes releasing the occlusion device andwithdrawing the delivery system and the catheter from the patient.

FIGS. 11A and 11B illustrate an example of the braid, or braided mesh100. The mesh 100 can be self-expanding and which can be comprised of atube of mesh. The self-expanding mesh 100 can include multiple wires102, for example from 4 to 96 wires. The number of wires 102, and thediameter of the wires can be a factor in controlling the stiffness andpore size. y. For example, the distal end of the braid can more porousor more flexible than the proximal end, or vice versa. The combinationof a braid with only one sack or multiple sacks (e.g., two or moresacks) can be taken into account when determining the number of wires.Fewer wires 102 can be used as a whole and still result in desiredocclusion. The wires 102 can be made from multiple alloys such as anickel-titanium alloy, cobalt chromium alloys, Platinum, Nitinol,Stainless Steel, Tantalum, or other alloys, or any other suitablebiocompatible materials, or combination of these materials, includingdeposited thin films. Also, these materials can be absorbable ornon-absorbable by the patient over time.

The apertures 104 in the mesh 100 create a substantially unitary framework or mesh in the wall 106. Thus, the apertures 104 may be of anysize, shape, or porosity, and may be uniformly or randomly spacedthroughout the wall 106 of the mesh 100. The apertures 104 provide thetubular element with flexibility and also assist in the transformationof the mesh 100 from the collapsed state to the expanded state, and viceversa.

As discussed above, the mesh 100 inverts as it forms. This means thatthe inside 108 of the mesh 100 when the mesh is formed, becomes the“outside” on deployment or is in contact with the aneurysm A wall, asillustrated in FIG. 11B. For clarity, the mesh 100, is initially formedas a hollow cylindrical shape. This shape has an inside 108 and anoutside. The inside 108 being akin to the hollow portion of a tube. Upondeployment, the mesh 100 is turned inside-out so the “inside” 108 onformation is now the “outside” of the sack 112 once deployed in theaneurysm A.

Note that the mesh 100 has a length L and that length L forms both thesack 112 and the unexpanded mesh 110 (or “tail”) that forms within thesack 112. Controlling the length L can provide differing diameters ofthe sack 112, the number of internal sacks and/or the length of the tail110 that fills the sack 112 and affects packing density.

In one example, the inversion of the mesh 100 can be formed when theproximal end 114 of the mesh 100 is pushed forward while the distal end116 remains fixed. The proximal end 114 is pushed inside 108 forcing theproximal end 114 to exit the delivery tube first while end 116 remainsfixed. Once the entire length L is deployed out of the delivery tube,the distal end 116 is detached and is thus the last end to be deployed.As above, the proximal end 114 engages the proximal implant end 14 andthe distal end 116 engages the distal implant end 16. The mesh 100 canbe formed akin to a tube sock.

Another example fixes the distal end 116 as above, and as the proximalend 114 is pushed, the mesh 110 just behind the distal end 116 isdeployed, still causing the mesh 100 to deploy “inside out.” Here, oncethe mesh 100 is fully deployed, both the proximal and distal ends 114,116 are next to each other.

FIG. 11C illustrates the mesh 100 post-deployment with an embolic coil330 at the proximal end 114 which can be opened. With end 114 beingopened, the embolic coil 330 may be inserted therethrough to increasepacking density of the corresponding occlusive sack or otherwise supportthe occlusive sack in certain aneurysm morphologies, such as aneurysmswith wide necks. Coil 330 be made with any biocompatible materialscommonly used in the art such as nickel-titanium alloy, cobalt chromiumalloys, Platinum, Nitinol, Stainless Steel, Tantalum, or other alloys;or any other suitable biocompatible materials, or combination of thesematerials. The stiffness of the coil 330 can be adjusted by, forexample, typical coil parameters of coil wire diameter, coil wounddiameter, coil pitch, and coil material. In the instance of a coil, thediameter of the coil is selected in consideration of the size and shapeof the aneurismal sac A, which can be a variety of shapes and sizes.

FIGS. 12A-12I depict example embodiments of braid 10 being delivered toan example aneurysm A. Specifically, in FIG. 12A, braid 10 can be seenbeing initially advance into aneurysm A and sack 12 beginning to takeshape. In FIG. 12B, it can be seen that braid 10 continues to bedistally advanced toward dome D of aneurysm A and folds into itself toform sack 12. However, braid 10 is not so limited and in certainembodiments as braid 10 exits catheter 20, braid 10 can begin invertingto form sack 12 without a break 13 and independent of its positionrelative to dome D. “The term “break” is used herein to include a regionof the braid that facilitates inversion and/or avoid kinking of thebraid during delivery. The break can include one or more local changesin physical properties with respect to other regions of the braid (e.g.,increased flexibility, pre-weakened, etc.). Sack 12 is radiallyexpanding toward the walls of aneurysm A while unexpanded portions 17 ofbraid 10 continue to be translated. It is understood that break 13 maybe formed into the interstices of braid 10 so that inverted, foldingoccurs after braid 10 has distally translated a predetermined distance.Break 13 may include localized heat treatment to render braid 10 moreductile but kink preventative and induce a gradual folding curve. Inthis respect, the break 13, including localized heat treatment, canrender braid 10 capable of expanding after inverting. Break 13 may alsobe simply be a weak point or buckling point pre-set for a particularsack 12 so that buckling is induced so as to avoid strain of aneurysm A.Alternatively, no break 13 may be included and instead braid 10 mayinvert and fold into itself upon contacting the dome D of aneurism Abased on pre-selected pliability of braid 10.

In certain embodiments, sack 12 can be sized for only a specific sizedaneurysm A. However, in other embodiments, sack 12 can be conformable oradjusted by the operator to sufficiently pack aneurysms across multiplesizes (e.g. across approximately 6 mm to approximately 10 mm) bycontinuing to advance portion 17 so that sack 12 is adjusted, as needed.For example, translating portion 17 distally from first to secondpositions can adjust from a first occlusion setting to a second setting.This is particularly advantageous in a clinical setting since it meansthat accurate measuring of aneurysm A is unnecessary and instead, sack12 can be precisely and safely adjusted to fit aneurysm A in a mannerthat occludes without risk of rupture.

In FIG. 12C, sack 12 is nearly fully formed and in FIG. 12D, portions 17have been distally translated so that sack 12 is fully formed with noadditionally portions necessary to expand. In FIG. 12D specifically, itcan be seen that formed sack 12 is now adjacent and supporting dome D.Braid 10 meanwhile may continue to be translated to form one or moreadditional sacks internal to sack 12 in order to overlay sack 12 todecrease porosity and/or further slow flow into the aneurysm. Forexample, in FIG. 12E, a second break may be included in braid 10 so thatas portion 17 continues to be translated distally, a second sack 15 canbegin to form and invert into itself. In FIG. 12F, portion 17 hasdistally translated more so that second sack 15 is now fully formed andoverlaid internal to sack 12. In FIGS. 12G-12I, after formation of sacks12, 15, portion 17 may continue to be distally translated while otherportions of braid 10 no longer invert. In this respect, portion 17 canbe considered a non-inverted portion of braid 10 proximal of sacks 12,15. Portion 17 distally translates to fill sack 15 with portions 17,similar to a coil approach. However, unlike a coil approach, portions 17can both fill sacks 12, 15 and then be retracted therefrom if anoperator desires to re-position or re-set braid 10 with aneurysm A. Thepacking density of sack 12 can be adjusted by distally or proximallyadvancing portions 17 between one or more predetermined (e.g. a firstsetting of 15%, a second setting of 20%, a third setting of 25% etc).Rates of fluid occlusion can also be optimized by varying porositythroughout braid 10, including ends 14, 16, portion 17, and/or sacks 12,15. The depicted embodiments here are merely example approaches of theherein disclosed braid 10. Other embodiments could include only oneocclusive sack or more than two example occlusive sacks as depicted.

It is understood that variations of the braid 10 can include variousmaterials such as stainless steel, bio absorbable materials, andpolymers. Braid 10, including any specific portions such as any breaksand corresponding sacks, can be heat set to various configurations suchas spherical, oblong, saddle shaped, etc. for the purpose of shaping theinitial sack to better match the aneurysm morphology. In addition, thebraid 10 can be heat shaped to include weak points to facility the braidbuckling once it reaches the dome of the aneurysm.

It is also understood that any sack formed by the herein discussedbraids 10 can be in a spherical shape as depicted or any other shape, asneeded or required, such as ellipsoidal, heart-shaped, ovoid,cylindrical, hemispherical, or the like. Further, interstices of braid10 that form the sack can vary, or be selectively designed, in size orshape along its length depending on how much braid 10 is caused toradially expand as pushing mechanism 38 is distally moved.

The specific configurations, choice of materials and the size and shapeof various elements can be varied according to particular designspecifications or constraints requiring a system or method constructedaccording to the principles of the disclosed technology. Such changesare intended to be embraced within the scope of the disclosedtechnology. The presently disclosed embodiments, therefore, areconsidered in all respects to be illustrative and not restrictive. Itwill therefore be apparent from the foregoing that while particularforms of the disclosure have been illustrated and described, variousmodifications can be made without departing from the spirit and scope ofthe disclosure and all changes that come within the meaning and range ofequivalents thereof are intended to be embraced therein.

ASPECTS OF THE INVENTION

1. A system for treating an aneurysm comprising:

a braid having a distal implant end opposite a proximal implant end, thebraid having a lumen;

wherein the braid is configured such that distal translation of theproximal implant end toward the distal implant end causes the distalimplant end to invert and fold into itself, thereby forming an occlusivesack for occluding an aneurysm.

2. The medical device of aspect 1, wherein the braid is a self-expandingbraid.

3. The medical device of aspect 1 or aspect 2, wherein the outer surfaceof the braid is self-expanding.

4. The medical device of any preceding aspect, wherein the braid isconfigured to assume a predetermined occlusive sack shape.

5. The medical device of any preceding aspect, wherein the occlusivesack is configured to be substantially spherical in shape.

6. The medical device of any of aspects 1 to 5, wherein the occlusivesack is configured to conform in shape to an asymmetric aneurysm or ananeurysm with multiple sacs.

7. The medical device of any of aspects 1 to 5, wherein the occlusivesack is a collapsible cage-like vaso-occlusive structure.

8. The medical device of any preceding aspect, wherein an outer surfaceof the braid is comprised of a plurality of interstices.

9. The medical device of aspect 8, wherein dimensions of the intersticesvary at the distal implant end versus the proximal implant end.

10. The medical device of any of aspects 1 to 7, wherein at least aportion of the braid defines a plurality of interstices with openingsfor occlusion of the aneurysm.

11. The medical device of any preceding aspect, wherein the braid isconfigured to be of a length sufficient that non-inverted portions ofthe braid not forming the occlusive sack fold into the occlusive sack,as distal translation continues, to increase packing density of theocclusive sack.

12. The medical device of any preceding aspect, wherein the proximalimplant end is less pliable and/or has less material strength than thedistal implant end.

13. The medical device of any preceding aspect, wherein the braid isfurther configured to form, upon continued distal translation, a secondsack within the occlusive sack, each sack being formed from the braidinverting and folding into itself.

14. The medical device of any preceding aspect, wherein the braidfurther comprises a break disposed between the distal and proximalimplant ends, the break configured to cause the occlusive sack to formwhen the distal implant end is distally translated toward the aneurysm.

15. The medical device of aspect 14 when dependent upon aspect 13,wherein the braid further comprises a second break disposed between thefirst break and the proximal implant end, the second break configured tocause the second sack to form upon continued distal translation.

16. The medical device of any preceding aspect, further comprising anembolic coil at the end of the proximal implant end.

17. The medical device of any preceding aspect, further comprising adelivery system; wherein the proximal implant end or embolic coil isoperable to attach mechanically to the delivery system, the deliverysystem comprising a catheter and a pushing mechanism disposed in thecatheter, the pushing mechanism operable to translate the braid.

18. A delivery system for an occlusive device for treating an aneurysm,comprising:

a delivery tube comprising a distal end and a proximal end, the deliverytube being slidably disposable within a microcatheter; and

a pushing mechanism slidably disposed with or within the delivery tube,the pushing mechanism comprising a distal end and a proximal end;

the medical device of any of aspects 1 to 16 slidably disposed withinthe delivery tube and mechanically attached to the pushing mechanism,

wherein the pushing mechanism is operable to distally translate themedical device to a deployed condition for occluding the aneurysm;

wherein the translation is in a distal direction thereby forming theocclusive sack for the aneurysm.

19. The system of aspect 18, wherein the distal implant end of the braidis detachably attached adjacent the distal end of the delivery tube suchthat the braid begins inverting to form the occlusive sack immediatelyas the braid exits the distal end of the delivery tube.

20. The system of any of aspects 18 and 19, further comprising:

an imaging device operatively connected to the occlusive device, whereinthe imaging device is capable of imaging the sack with respect to theaneurysm; and

wherein an orientation and/or packing density of the occlusive sack isadjustable by the braid being distally or proximally moved.

21. The system of any of aspects 18 to 20, wherein the proximal implantend of the braid is detachably attached to the distal end of the pushingmechanism.

22. The system of any of aspects 18 to 21, wherein the proximal implantend of the braid is attached to and foldable over an inner portion ofthe pushing mechanism.

23. The system of any of aspects 18 to 22, wherein the distal end of thedelivery tube comprises opposed gripping arms, one or both gripping armsbeing pivotable away from the other gripping arm to release the braidfrom the delivery tube.

24. The system of any of aspects 18 to 23, wherein the pushing mechanismfurther comprises an inner passage through which at least one emboliccoil is insertable into the braid when the braid forms a sack within theaneurysm.

25. The system of any of aspects 18 to 24, wherein the distal end of thepushing mechanism comprises radiopaque material.

What is claimed is:
 1. A method of delivering an occlusion device to ananeurysm, comprising: positioning the occlusion device within a tubulardelivery tube, the tubular delivery tube comprising a distal endreleasably connected to a distal implant end of the occlusion device,the occlusion device comprising a self-expanding braided tubular implantcomprising the distal implant end and a proximal implant end, thebraided tubular implant being invertible about the distal implant end;distally sliding the braided tubular implant toward the aneurysm therebyexpanding the distal implant end of the braided tubular implant from acollapsed condition to a deployed condition; and causing the distalimplant end of the braid to invert and fold into itself and form anocclusive sack configured to occlude the aneurysm.
 2. The method ofclaim 1, wherein the distal implant end of the braided tubular implantbegins expanding immediately as the braided tubular implant exits adistal end of the delivery tube.
 3. The method of claim 1, furthercomprising: selectively positioning a microcatheter in the vasculature;and positioning the occlusion device assembled with the delivery tubeinside the microcatheter.
 4. The method of claim 1, wherein the sackwhen formed comprises a predetermined packing density range.
 5. A methodof delivering an occlusion device to an aneurysm, comprising:positioning an occlusion device within a delivery tube, the occlusiondevice comprising a self-expanding braid; distally sliding the braidtoward the aneurysm thereby expanding a distal implant end of the braidfrom a collapsed condition to a deployed condition; inverting the distalimplant end of the braid to form an occlusive sack configured to occludethe aneurysm; and continuing to distally slide the braid toward theaneurysm after formation of the first sack thereby changing a packingdensity of the occlusive sack with one or more unexpanded portions ofthe braid.
 6. The method of claim 5, the braid further comprising: afirst break defined by a size of the sack for packing the aneurysm; anda second break on the braid after of the first break; the method furthercomprising: distally sliding the braid toward the aneurysm afterformation of the first sack; and inverting the braid at the second breakto form a second sack within the first sack.
 7. The method of claim 5,further comprising: distally sliding the braid toward the aneurysm afterformation of the first sack; and inverting the braid to form a secondsack within the first sack.
 8. The method of claim 5, furthercomprising: continuing to distally slide the braid toward the aneurysmafter formation of the first sack thereby packing the sack with one ormore unexpanded portions of the braid.
 9. The method of claim 5, furthercomprising: determining a position of the sack relative to the aneurysm;and if the position fails to satisfy a fitting threshold with theaneurysm, then proximally sliding the braid thereby causing the sack tocollapse back into the braid; and withdrawing the braid from theaneurysm.
 10. A system for an occlusive device for treating an aneurysm,comprising: a delivery tube comprising a distal end and a proximal end,the delivery tube being slidably disposable within a microcatheter; anda pushing mechanism slidably disposed with or within the delivery tube,the pushing mechanism comprising a distal end and a proximal end; theocclusive device being slidably disposed within the delivery tube andmechanically attached to the pushing mechanism, the occlusive devicecomprising a braid having a distal implant end and a proximal implantend, wherein distally translating the braid, by the pushing mechanism,causes the distal implant end to invert and fold into itself therebyforming an occlusive sack for the aneurysm.
 11. The system of claim 10,wherein the distal implant end of the braid begins inverting to form theocclusive sack immediately as the braid exits a distal end of thedelivery tube.
 12. The system of claim 10, wherein the proximal implantend of the braid is attached to and foldable over an inner portion ofthe pushing mechanism.
 13. The method of claim 1, further comprising:occluding the aneurysm with the occlusive sack.
 14. The method of claim1, the distal implant end being substantially atraumatic or rounded andconfigured to minimize kinking of the braided tubular implant duringinversion.